Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube
NCT ID: NCT02609620
Last Updated: 2015-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2015-12-31
2016-10-31
Brief Summary
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Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction on predetermined intervals and analysed for Pepsin A concentration.
The PFT will be removed upon completion of the study's scheduled routine. Patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment
In the treatment group: The LunGuard Peristaltic Feeding Tube (PFT) will be positioned in the ICU and positioning will be verified by X-ray. Nutritional formula will be fed into the stomach via the feeding lumen of the PFT
Peristaltic Feeding Tube
Control
Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard.
ConvaTec Levin Duodenal Tube
Interventions
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Peristaltic Feeding Tube
ConvaTec Levin Duodenal Tube
Eligibility Criteria
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Inclusion Criteria
* Patients who are expected for at least 12 hours to be:
* Mechanically ventilated and sedated.
* Requiring a nasogastric tube.
* Included are:
* Patients who have undergone tracheostomy.
* Patients who require use of pro-kinetic drugs and proton pump inhibitors.
* All levels of Gastric Residual Volume (GRV)
Exclusion Criteria
* Patients with a known esophageal obstruction, preventing passage of the device.
* Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor GERD patients)
* Acute and severe coagulation disorders
* (INR\> 2 or platelets below 30,000)
* Diabetic patients with documented gastrointestinal neuropathy
* Pregnancy or lactation
* Allergy to Silicon
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
18 Years
85 Years
ALL
No
Sponsors
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LunGuard Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Philip Biderman, MD
Role: PRINCIPAL_INVESTIGATOR
Bellinson Hospital
Central Contacts
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Other Identifiers
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PROT-150630835CTIL
Identifier Type: -
Identifier Source: org_study_id